PRODUCT OR SERVICE PROVISION; CONTROL OF NONCONFORMIING PRODUCT

QUESTION EVIDENCE FOLLOW- CAR #, IF

UP APPLICABLE
REQUIRED?
Production and service provision—Clause 8.5
(this checklist is to be used in conjunction with
the “All Processes” checklist)

1. How is production scheduled to ensure that ship

dates or delivery dates are met? Is the schedule
appropriate? Is it realistic or does meeting it
often require extraordinary measures?

2. What measurement or monitoring activities are

required in the process to verify that criteria for
control has been met? May I see them please?
(Select X measurements and verify the following
questions:)

a. Are acceptance limits defined and

documented? Are they available to the
operator?

b. (Do records show evidence that the

parameters are within specified limits? If not,
was action taken as specified in the
procedures? Record records reviewed and
results found to the right.)

3. Does the organization have any processes in

which the final product cannot be verified by
subsequent monitoring and measurement? If so,
how are these processes validated, and re-

Production and Service Provision

 validated as necessary, to demonstrate that
planned results are achieved? (Review records
to verify conformance.)

4. What actions have been taken to prevent human

error in the process?

5. Describe the process for releasing and shipping

product to ensure that only acceptable product is
shipped to the correct customer. (Verify
conformance to procedures.)

Identification and traceability—Clause 8.5.2

1. How are incoming materials, in-process
materials, and final products clearly identified?

2. (Walk through storage and production areas to

verify conformance to the procedures. Note any
exceptions to the right.)

3. What are the traceability requirements for your

organization? (Pull records to verify
conformance to traceability requirements.)

4. How is inspection and test status of incoming

materials, in-process materials, and final
products identified?

5. (Walk through the facility and verify

conformance to procedures.)

Property belonging to customers or external

parties—Clause 8.5.3

Production and Service Provision

1. What customer property—or property from
other external providers—does the organization
have under its control? (Note: This could include
parts, materials, tools, equipment, shipping
containers, intellectual property, personal data,
and so on.) How is this property identified,
verified, protected, and safeguarded? (Walk
through storage areas and review records to
verify conformance to procedures.)

2. What process is in place to notify customers or

external providers of any problems associated
with their property? Are records maintained?
(Review records to verify conformance.)

Preservation—Clause 8.5.4

1. How are products or other outputs preserved

throughout the operation to protect their fitness
for use? (For example, what specific handling
and storage issues do you have at your
organization? Electrostatic discharge concerns?
Shelf lives on products, materials, or lab
reagents? Fork truck damage? Temperature
and/or humidity of storage areas? Double and
triple stacking of cartons that crush the bottom
carton? Torn bags in storage? And so on.)

2. (Pull records as required and walk through

storage areas to verify conformance to
procedures.)

Production and Service Provision

3. How does the organization ensure that product is
packaged and labeled to meet any requirements?
(Observe product being packaged. Ensure that
correct procedures are being followed. Trace the
packaging and labeling instructions back to
customer packaging requirements, if applicable,
to verify conformance.)

Post-delivery activities—Clause 8.5.5

1. What post-delivery activities is the organization

responsible for? (Note: Post-delivery activities
may include warranty provisions, maintenance
activities, recycling, disposal, and so on.)

2. In defining post-delivery requirements, how did

the organization consider such things as
statutory and regulatory requirements; potential
undesired consequences; nature, use and
expected lifetime of products and services; as
well as customer requirements and feedback?
(Review requirements and verify conformance.)

Control of changes—Clause 8.5.6

1. How does the organization review and control

changes to production and service processes?
(Identify X recent changes. Review records to
verify that they include evidence of the review,
the person(s) authorizing the change, and any
actions taken resulting from the review.)

2. (Verify that appropriate personnel were made

Production and Service Provision

 aware of the change and that any new or revised
processes have been fully implemented.)

Work environment—Clause 7.1.4

1. (Verify throughout the audit that the appropriate

work environment exists to achieve conformity
to customer requirements. Examples may
include appropriate lighting in production and
inspection areas, housekeeping issues,
inappropriate heat or humidity, and so on.)

Production and Service Provision